Introduction

Installation qualification and operational qualification is implemented with and illustrated by the use of the validate_iqoq sample driver, located in the sample study library directory/cst-framework-1.5/programs folder. This is a two-step process.
  1. Select the CST-FRAMEWORK standard, and run the checks that are defined in the validation_control_glmeta view of the internal validation validation_master data set.
    This is a set of 64 checks (checkid < CSTV100) that look only at the global standards library metadata folder.
  2. Select 1 to n specific standards, and run the checks that are defined in the validation_control_stdiqoq view of the internal validation validation_master data set.
    This is a set of 30 checks (checkid > CSTV100 that are relevant to installation qualification and operational qualification issues) that look only at the metadata libraries other than the global standards library metadata folder.
Note: The validation Results data set that is generated by the internal validation installation qualification and operational qualification contains many observations. Your number of observations can differ from the numbers shown in this document due to installation configurations that differ from a default installation of the SAS Clinical Standards Toolkit. For example, CDSIC SEND might not be installed.